New Contact Lens Passes FDA for the Treatment of Myopia

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contacts from southland eye

New Contact Lens Passes FDA for the Treatment of Myopia

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FDA Approves Myopia Control Contact Lens: MiSight

Myopia, also known as nearsightedness, is reaching epidemic levels. Myopia control is the area of vision care dedicated to slowing myopia. Myopia often progresses through early adulthood. It was previously thought that myopia could not be controlled. Research is now showing that nearsightedness may be slowed with the use of some or all of specialized contact lenses, eye drops, and specialized eyeglass lenses. Slowing the progression might lower the final level of nearsightedness reached at adulthood, and can have a huge impact of adult vision disorders associated with nearsightedness such as retinal disease, retinal detachment, and glaucoma.

The new MiSight contact lens is a welcome addition to our treatment options we provide to our patients entering our Myopia Control Program at Southland Eye Associates.

Below is the full press release:

The U.S. Food and Drug Administration today approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment. The MiSight contact lens is a single use, disposable, soft contact lens that is discarded at the end of each day, and is not intended to be worn overnight.

“Today’s approval is the first FDA-approved product to slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems,” said Malvina Eydelman, M.D., director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.

Myopia is the most frequent cause of correctable visual impairment worldwide. Myopia occurs when the eye grows too long from front to back (axial length). Instead of focusing images on the retina, images are focused at a point in front of the retina. As a result, people with myopia have good near vision, but poor distance vision that can be corrected with glasses or contact lenses.

Myopia is common in children and tends to increase as they get older. If a person develops severe myopia as a child, they may be susceptible to other eye problems such as early cataracts or a detached retina during adulthood. The MiSight soft contact lenses are meant to be worn daily to correct nearsightedness and slow the progression of myopia in children with healthy eyes. When placed on the eye, one part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, similar to a standard corrective lens. In addition, concentric peripheral rings in the lens focus part of the light in front of the retina (the back of the eye). This is believed to reduce the stimulus causing the progression of myopia.

The approval of MiSight was based on data obtained from a prospective clinical trial at four clinical sites and real-world evidence. The safety and effectiveness of MiSight was studied in a three-year randomized, controlled clinical trial of 135 children ages 8 to 12 at the start of treatment who used MiSight or a conventional soft contact lens. The trial showed that for the full three-year period, the progression in myopia of those wearing MiSight lenses was less than those wearing conventional soft contact lenses. In addition, subjects who used MiSight had less change in the axial length of the eyeball at each annual checkup. Over the course of the trial, there were no serious ocular adverse events in either arm of the study.

Additionally, to estimate the rate of vision-threatening corneal infections (i.e., corneal ulcers) among children and adolescents who wear soft contact lenses daily, the FDA reviewed real world data from a retrospective analysis of medical records of 782 children ages 8 to 12 years old from seven community eye care clinics. The results showed a rate comparable to the rate of ulcer cases among adults who wear contact lenses daily.

As part of the approval of MiSight, the sponsor is required to conduct a postmarket study of the contact lenses to further evaluate the safety and effectiveness of the product as indicated.

The FDA granted approval of MiSight to CooperVision Inc. The device was approved using the Premarket Approval (PMA) pathway. Premarket approval is the most stringent type of device marketing application required by FDA and is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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Novartis receives FDA approval for Beovu®, offering wet AMD patients a new option

Basel, October 8, 2019 — Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Beovu® (brolucizumab) injection, also known as RTH258 for the treatment of wet age-related macular degeneration (AMD)[1]. Beovu is the first FDA approved anti-VEGF to offer both greater fluid resolution versus aflibercept and the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase[1] with uncompromised efficacy.

Read the full press release


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Welcome Dr. Birva K. Shah

Dr. Lipschultz Welcomes Dr. Birva K. Shah to Southland Eye!

Dr. Lipschultz is proud to announce, and welcome, Dr. Birva K. Shah to the practice, beginning in the November of 2019.

Dr. Shah is a residency trained optometrist, specializing in pediatric and contact lens care. She has extensive experience with binocular vision disorders, including strabismus, amblyopia, and convergence/accommodative disorders.  She also has extensive training in specialty contact lenses, scleral contact lenses, and diagnosis and management of glaucoma, macular degeneration and diabetic eye disease.

Dr. Shah grew up on the western suburbs of Chicago, attended the Illinois College of Optometry in Chicago, is married, and has one lovely daughter.


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The Rising Cost of Insulin: An Unacceptable Situation

Prior to a meeting this morning I was enjoying a cup of coffee and the USA Today newspaper for March 22, 2019. The front page headline: “Insulin Cost Has Diabetics Desperate.” This article triggered my emotions for several reasons. Please click that link and read the article.

Firstly, I’ve noticed an increase in the number of patients I see in our Olympia Fields office with diabetes and the eye related effects of diabetes. Upon discussing life with diabetes with many patients, some have no issues with the cost of managing their diabetes thanks to their income, their insurance, or both. Other patients shared their struggles keeping up with the rising cost of insulin. Struggles that are truly life-threatening, as you will read in the USA Today article shared above. For example, patients are rationing their use to lower their costs, all at the expense of their health. Poorly controlled glucose will cause their A1C to rise, and ultimately triggering a wide range of health problems, including loss of vision. Loss of vision from a problem called diabetic retinopathy, which can range from partial vision loss (called low vision) all the way to total blindness.

I’ve also been somewhat shocked as to how little education many of my patients with diabetes have received from their physicians. Education on diet, exercise, and what I term as “the most important job they have today” – keeping their glucose reading steady and low, with a focus on getting their A1C down to the levels recommended by their doctors (usually an A1C reading of 6.1, but this number is continually scrutinized).

Secondly, at my home, our 15-year old kitty, Julie, was recently diagnosed with diabetes, and my wife Sue and I are now familiarizing ourselves with managing glucose levels, insulin shots twice a day, and restricted diet. Of course this is no comparison to what patients go through, but it was a bit of a shock. The first time I went in to my local pharmacy to purchase my first bottle of insulin for $184, floored me. That little bottle that lasts 28 days, which I will only use 10% of due to the tiny size of my kitty Julie.

Finally, a couple weeks ago a long-term friend came to visit with Sue and I from South Africa. We spent a great weekend showing her around Southern California, while she educated me on her life as an insulin-dependent person with diabetes. She shared that during the recent US government shutdown, she and many of her friends from around the world were sending either money, or actual insulin, to US residents who could not pay for their insulin due to their layoffs. To say the least, I was in shock. We’re the USA! This is insulin! A drug created nearly 100 years ago, and one that without it patients will die.

I don’t profess to have any answers to the issue of the cost, but I have a newly-expanded understanding of the economic issues surrounding insulin, and the pharmaceutical companies. It truly tears at my heart when a patient tells me their A1C is at sky-high levels, and it is primarily due to a lack of understanding about the horrible effects of poorly controlled diabetes, compounded by the fact they are often rationing their insulin to be able to pay bills and buy groceries, putting their vision and total health at risk.

So if you’re reading this as either a person with diabetes or a friend/relative of someone with diabetes, please remind them of a few rules for their own self-care:

  • Keep your A1C at or under the goal established by your managing physician.
  • Get your eyes dilated yearly, and more frequently if your glucose is poorly controlled
  • Exercise
  • Quit smoking
  • Follow a diabetic diet plan.

Dr. Lou Lipschultz


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november southland eye giveaway

Enroll in our November $1000 Giveaway!

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Enroll in our $1000 of FREE OPTICAL in our November Giveaway! It’s our way of saying THANK YOU to our many patients!

Glasses for yourself or family members? Sunglasses for everyone? Whatever you need!

There are no costs to enroll! Then, once you’re enrolled, you’ll receive brief instructions as to how you can receive additional chances to win by following on social media like Facebook or Instagram, or by telling friends about the Giveaway.

Enrollment closes November 17th 2017 at 5pm central time! Enroll Now!

 


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Happy child girl in eyeglasses reading books sitting at table

New Treatments to Slow Down Myopia Progression

Nearsightedness, (known in medical terms as myopia) is now considered an epidemic on a global basis. So many children are developing myopia that significant research is underway, searching for how to slow down the progression of this disorder.

There are several treatment options, some of which have been used for decades, but had very little scientific evidence that they truly worked. The most common options our office is now recommending to patients includes bifocal contact lenses, bifocal glasses, orthokeratology, and a low does eye drop called atropine.  We have explored all of these as reasonable treatment options.

Below is a link to an interesting article posted to the National Institute of Health website. For those of you who enjoy the meat of the research, here is a link to the summary.

If you have a child who you would like us to evaluate and explain the various myopia control treatment options, please contact the office at your convenience at 708-481-4600.

Interventions to Reduce Myopia Progression in Children.


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back to school savings

Back To School Eye Exams

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It’s hard to believe it, but it’s back to school time. Yep. time for trips to grab school supplies, clothes, and much more. But Don’t forget the back to school eye exams!

Check out our back to school deals on optical, contacts and more on our Back to School page!

 


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New Clinical Trial Starts: Convergence Insufficiency (CITT-ART Trial) Evaluated

Dr. Susan CotterDr. Lipschultz wife, Dr. Susan Cotter, continues to pursue the answers to various questions about children’s vision disorders. The CITT-ART multi-center clinical trial is underway! Read more about the CITT-ART clinical trial at www.citt-art.com.


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Northwestern researchers’ glaucoma breakthrough prompts new treatment development

Scientists at Northwestern’s medical school have uncovered a new cause of the eye disease glaucoma, spurring their research on a new eye drop to more sustainably treat the condition, the University announced Wednesday. READ MORE…


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